Chronic Sinusitis
Conditions
Interventions
We aim to investigate on efficacy and safety of TJ-50 for the patient who diagnosed with chronic sinusitis and received endoscopic sinus surgery. This study was an open-label randomized trial between
Sponsors
Hatakeyama Hiromitsu
KONDA AKIHITO
TSUMURA & CO.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient is diagnosed with chronic sinusitis 2) The patient is planned treatment by ESS(Endoscopic Sinus Surgery) 3) The patient can be treated with long-term, low-dose macrolide. 4) 20 to 80 years old 5) Both gender6)Written informed consent of this study is obtained from the patient
Exclusion criteria
Exclusion criteria: 1) The patients scheduled to undergo surgical procedures other than ESS as a treatment for chronic sinusitis 2) The patients suspected of typical eosinophilic sinusitis 3) The patients complicated of aspirin asthma 4) The patients complicated with bronchial asthma 5) The patients complicated of NSAIDs allergy 6) Pregnant women, lactating women, and patients who have the possibility or intention of pregnancy 7) The patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study 8) The patients judged unsuitable by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A score of the QOL by the patient using SNOT-22 at 3 months after the ESS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Nasal mucosal findings (Baba's score) 2) Colony Forming Unit (CFU) in the nasal cavity 3) Olfactory survey (VAS) 4) Laboratory test values (WBC, leukocyte fraction (neutrophils, eosinophils, basophils, lymphocytes, monocytes)) | — |
Contacts
Public ContactHiromitsu Hatakeyama
Yokohama city university medical center
Outcome results
None listed